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A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty

2026年5月12日 更新者:Muhammad Israr、Shaikh Zayed Hospital, Lahore

This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum.

The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft.

The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.

研究概览

研究类型

介入性

注册 (实际的)

92

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、54000
        • Shaikh Zayed Medical college/hospital, Lahore

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged 18 to 60 years.
  • Patients of either gender.
  • Patients diagnosed with chronic otitis media.
  • Patients with inactive mucosal disease, with no active ear discharge.
  • Patients with a large central perforation of the tympanic membrane.
  • Tympanic membrane perforation persisting for at least 6 weeks.
  • Patients with pure conductive hearing loss confirmed on pure-tone audiometry.

Exclusion Criteria:

  • Patients with active otitis media, acute infection, or active ear discharge.
  • Patients with tympanosclerosis or ossicular necrosis affecting ossicular chain mobility.
  • Patients with a history of previous ear surgery that could affect tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy, except prior myringotomy.
  • Patients with sensorineural hearing loss or mixed hearing loss.
  • Patients with conditions impairing wound healing or postoperative care compliance, including uncontrolled diabetes mellitus or immunodeficiency disorders.
  • Patients with confirmed Eustachian tube dysfunction.
  • Patients with active infection in the throat, nose, paranasal sinuses, or oral cavity.
  • Patients with bleeding disorders.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group Wet Temporalis Fascia Graft
Participants in this group underwent tympanoplasty using the wet temporalis fascia graft technique for repair of tympanic membrane perforation.
Tympanoplasty was performed using a wet temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry
有源比较器:Group Dry Temporalis Fascia Graft
Participants in this group underwent tympanoplasty using the dry temporalis fascia graft technique for repair of tympanic membrane perforation.
Tympanoplasty was performed using a dry temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean hearing gain after tympanoplasty
大体时间:3 months after surgery
Mean hearing gain was measured by comparing the preoperative and postoperative air-bone gap on pure-tone audiometry. The air-bone gap was assessed at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Mean hearing gain was calculated by subtracting the postoperative air-bone gap from the preoperative air-bone gap. A greater reduction in air-bone gap indicated better hearing improvement after tympanoplasty.
3 months after surgery
Graft uptake rate after tympanoplasty
大体时间:3 months after surgery
Graft uptake rate was assessed by otoscopic examination. A successful graft uptake was defined as an intact and correctly positioned graft with closure of the tympanic membrane perforation, without evidence of graft rejection or active infection.
3 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Complete Air-Bone Gap Closure
大体时间:3 months after surgery
Complete air-bone gap closure was defined as a postoperative air-bone gap of 10 dB or less on pure-tone audiometry. This outcome was used to assess clinically meaningful improvement in conductive hearing loss after tympanoplasty.
3 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hafiz Adil Ikram、Shaikh Zayed Hospital, Lahore

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月10日

初级完成 (实际的)

2026年3月10日

研究完成 (实际的)

2026年3月10日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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